NCT01562288

Brief Summary

RATIONALE: Studying samples of blood and DNA in the laboratory from patients who received chemotherapy with or without trastuzumab may help doctors learn more about the effects of trastuzumab on cells. It may also help doctors understand how well patients respond to treatment. PURPOSE: This research trial studies blood and DNA samples from patients with breast cancer treated with chemotherapy with or without trastuzumab.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 2, 2019

Status Verified

July 1, 2019

Enrollment Period

7.2 years

First QC Date

March 21, 2012

Last Update Submit

July 1, 2019

Conditions

Breast Cancer

Keywords

HER2-positive breast cancerHER2-negative breast cancerstage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancer

Outcome Measures

Primary Outcomes (2)

  • disease-free survival

    up to 1 month

  • overall survival

    up to 1 month

Study Arms (1)

Observational

Previously collected serum and DNA from peripheral blood mononuclear cell samples are analyzed for HER2-specific antibodies and FcγR genotype by ELISA and PCR.

Genetic: DNA analysisGenetic: gene expression analysisGenetic: polymerase chain reactionOther: enzyme-linked immunosorbent assayOther: laboratory biomarker analysis

Interventions

DNA analysisGENETIC
Observational
gene expression analysisGENETIC
Observational
polymerase chain reactionGENETIC
Observational
enzyme-linked immunosorbent assayOTHER
Observational
laboratory biomarker analysisOTHER
Observational

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled on NCCTG-N9831.

• Patients with HER-2-overexpressing node-positive or high-risk node-negative breast cancer enrolled on NCCTG-N9831 \* Pre- and post-treatment serum and DNA samples of patients treated with doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab (Herceptin®)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Serum and DNA extracted from peripheral blood mononuclear cell samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gene Expression ProfilingPolymerase Chain ReactionEnzyme-Linked Immunosorbent Assay

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic TechniquesInvestigative TechniquesNucleic Acid Amplification TechniquesImmunoenzyme TechniquesImmunoassayImmunologic TechniquesImmunosorbent TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Keith L. Knutson, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2012

First Posted

March 23, 2012

Study Start

February 1, 2012

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 2, 2019

Record last verified: 2019-07